当指令93/42/EEC第7.5节第2段附录I要求时，BS EN 15986:2011规定了医疗器械或医疗器械零件的标签要求，以表明存在邻苯二甲酸酯。这具体包括标签中使用的符号格式。BS EN 15986:2011未规定医疗器械提供信息的要求，这些信息包括: 由EN 980和EN 1041解决。BS EN 15986:2011未规定基本要求7.5第1段和第3段的要求。交叉引用:93/42/EEC67/548/EECRegulation（EC）No 1272/2008ISO 7000EN 12264:2005prEN ISO 15223-1:2009ISO/DIS 15223-1:2009EN 80416-3:2002IEC 80416-3:2002EN 980:2008ISO 15223-1:2007EN 1041购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN 15986:2011 specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling.BS EN 15986:2011 does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041. BS EN 15986:2011 does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.Cross References:93/42/EEC67/548/EECRegulation (EC) No 1272/2008ISO 7000EN 12264:2005prEN ISO 15223-1:2009ISO/DIS 15223-1:2009EN 80416-3:2002IEC 80416-3:2002EN 980:2008ISO 15223-1:2007EN 1041All current amendments available at time of purchase are included with the purchase of this document.